Kornimate/medical-research-clean huggingface dataset:
prospective clinical evaluation of the filmarray respiratory panel 2

Conditions: Upper Resp Tract Infection

Summary: this is a performance study to test the sensitivity and specificity of the biofire filmarray respiratory panel (rp) 2. the purpose of this study is to prospectively collect and test residual nps specimens and generate performance data to support regulatory classification of the filmarray rp2 as an in vitro diagnostic (ivd) in the us, european union (eu), canada, and other regions.

the filmarray respiratory panel 2 (rp2) is an automated sample-to-answer pcr-based diagnostic for the identification of common upper respiratory viral and bacterial pathogens in nasopharyngeal swab (nps) specimens collected in viral transport media (vtm). the purpose of this study is to prospectively collect and test residual nps specimens and generate performance data to support regulatory classification of the filmarray rp2 as an in vitro diagnostic (ivd) in the us, european union (eu), canada, and other regions. clinical performance evaluations will be initiated at sites in the us and/or eu during the 2016/2017 respiratory illness season, approximately september through december.prior to performing the prospective clinical evaluation, each participating site will have the necessary institutional review board (irb) reviews (or equivalent for non-u.s. sites). specimens for inclusion in this study will be residual, de-identified nps collected in vtm leftover from clinician-ordered respiratory pathogen testing. comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory. this study is funded by biofire diagnostics, llc. the filmarray device conforms to the requirements of the european union in vitro diagnostic directive (ivdd). this study was designed such that every precaution has been taken to protect the health and safety of patients, users, and other persons.

Eligibility criteria:
inclusion criteria: * specimen is residual nps in vtm left over from standard of care testing under clinician order for respiratory pathogen analysis * specimen has been held at appropriate temperature * sufficient volume remaining after standard of care testing and available for use in the study exclusion criteria: * specimen other than nps in vtm (e.g. nasopharyngeal aspirate, anterior or midturbinate swab, oropharyngeal swab, nps collected in medium other than vtm) * specimen cannot be tested within the defined storage parameters * insufficient specimen volume for testing
evaluation of adg20 for the prevention of covid-19

Conditions: COVID-19

Summary: this placebo-controlled study is intended to evaluate adg20's safety and ability to prevent covid-19 infection.

phase 2/3, multicenter, double-blind, placebo-controlled, randomized study of the mab adg20 in the prevention of symptomatic covid-19 in adults and adolescents with no known history of sars-cov-2 infection but whose circumstances place them at increased risk of acquiring sars-cov-2 infection and developing symptomatic covid-19. this objective was independently evaluated in a cohort of participants with reported recent exposure to an individual diagnosed with a sars-cov-2 infection (post-exposure prophylaxis) and in a cohort of participants with no reported exposure to sars-cov-2 (pre-exposure prophylaxis). these cohorts included participants whose advanced age (≥55 years old) or health status placed them at risk for severe covid-19 or covid-19 complications.

Eligibility criteria:
inclusion criteria: * tests negative for current or previous sars-cov-2 infection by rt-pcr and serology (pre-exposure population only) * is at high risk of sars-cov-2 infection as assessed by the investigator: 1. post-exposure population: exposure to an individual with a diagnosis of sars-cov-2 infection (index case). note: participants with recent exposure to a laboratory-confirmed index case must be asymptomatic and randomized within 5 days (120 hours) of collection of the index case's positive sars-cov-2 diagnostic test. 2. pre-exposure population: occupational, housing, recreational and/or social conditions that are likely to increase risk of exposure to sars-cov-2. * agrees to defer receipt of covid-19 vaccination for minimum of 180 days (6 months) after dosing exclusion criteria: * has received (1) a sars-cov-2 vaccine, (2) mab or (3) convalescent plasma from a person who has recovered from covid-19 or prior participation in sars-cov2 vaccine, convalescent plasma, or mab clinical trial any time prior to participation in the study. * receipt of any investigational product within 30 days or 5 half lives before the day of enrollment. * is acutely ill or febrile 72 hours before or at screening or has other covid-19 symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or smell. fever is defined as a body temperature ≥38.0°c (≥100.4°f). * has received or plans to receive a non-covid-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing). note: other protocol defined inclusion/exclusion criteria apply

Keywords: adintrevimab, adg20, covid-19, prevention, prophylaxis
virtual reality vs. standard-of-care for comfort during laceration repair

Conditions: Laceration

Summary: lacerations are a common reason for presentation to the emergency department and children needing laceration repair with sutures are experiencing pain and anxiety. virtual reality (vr) is an immersive experience using sight, sound, and position sense. using vr may enhance distraction during the painful procedure and may reduce attention to pain. this study will randomize children (6 - 16 years old) to receive virtual reality or standard of care in addition to pharmacoanalgesia during a laceration repair procedure. investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.


Eligibility criteria:
inclusion criteria: * children age 6 - \<17 years * arriving to the emergency department with a chief complaint of laceration * the managing physician determines need for repair with suture * parents will sign a consent form and children will sign an assent form exclusion criteria: * children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) * triage category 1 (resuscitation) * facial features or injury prohibiting wearing vr goggles

Keywords: virtual reality pain anxiety
effect of chronic consumption of a cranberry beverage on inflammation and oxidative stress

Conditions: Inflammation

Summary: the objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. the investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. the investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.


Eligibility criteria:
inclusion criteria: * men \& women, aged 30-70 years * bmi 27-34.9 kg/m2 * waist:hip ratio \> 0.8 for women and \> 0.9 for men exclusion criteria: * cigarette smoking and/or nicotine replacement use within last 6 months * individuals taking estrogen or testosterone * use of cholesterol-lowering medications * use of blood pressure-lowering medications * regular use (\> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements) * cardiovascular (heart) disease * gastrointestinal disease * kidney disease * endocrine disease: including diabetes, untreated thyroid disease * rheumatoid arthritis * immune deficiency conditions * active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission * systolic blood pressure \> 139 mmhg and/or diastolic blood pressure \> 89 mmhg * regular use of systemic steroids, oral or injectable * regular daily intake of ≥ 2 alcoholic drinks * infrequent (\ 3/d) number of regular bowel movements * gain or loss of ≥ 5% of body weight in the last 6 months * pregnancy * strict vegetarians * no dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, st. john's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
the protection effect of speeda® rabies vaccine for human use

Conditions: Rabies Vaccine Allergy

Summary: the objective of this study was to achieve the post-marketing protective effect research of speeda® rabies vaccine for human use from chengda bio.

when found the injury who is bitten by the animal to three-level, the investigators would enroll the participant after explaining the protection and making him signed the informed consent. the patient would inject rabies vaccine as follow the national regulation, meanwhile the investigators would get the blood samples to detect whether the man-killer carries the rabies virus.

Eligibility criteria:
inclusion criteria: * parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed * participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured * the man-killer could found and detect whether it carries the virus exclusion criteria: * known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * apply passive immunity preparation
study of safety and efficacy on neuromyopathy of early standing with the assistance of tilt table in critically patients

Conditions: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU

Summary: critically ill patients frequently develop muscle weakness due to critical illness-related acute neuropathy and/or myopathy. this disorder is associated with difficulties in weaning from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased mortality rates. in addition, many patients continue to suffer from decreased exercise capacity and quality of life for months to years after the acute event. besides controlling risk factors, no specific prevention or treatment exists. recommendations advice to start early with active and passive exercise in critically ill patients (1). having critically ill patients alert and engaged in progressive rehabilitation leading to mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to improved strength and physical function (2). this randomized controlled trial was designed to investigate whether a daily training session using a tilt table, started early in stable critically ill patients with an expected prolonged icu stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at icu and hospital discharge compared to a standard physiotherapy program.


Eligibility criteria:
inclusion criteria: * patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours exclusion criteria: * polytrauma, * cerebral , spinal cord or spinal injury, * pelvic or lower limb fracture

Keywords: muscle weakness exercise therapy physiotherapy critical illness intensive care mechanical ventilation rehabilitation
the efficacy of salvia officinalis gel in the treatment of periodontitis clinical trial

Conditions: Periodontal Pocket

Summary: from each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and rsd with s. officinalis gel) or the control site (treated with scaling and rsd alone).

background: phytotherapy relies on the use of extracts derived from plants in pharmaceutical form. herbal products have been effective in reducing periodontal diseases, as stated by many studies. gingival crevicular fluid volume and concentrations of certain cytokines are precise and objective parameters in evaluating periodontitis treatment. aim of the study: assessment of local application of salvia officinalis (s. officinalis) gel as an adjunctive to scaling and root surface debridement (rsd) in the management of periodontitis. methods: a randomized clinical trial of split-mouth design for twenty-three subjects with periodontitis was assessed in this study. from each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and rsd with s. officinalis gel) or the control site (treated with scaling and rsd alone). a highly sensitive enzyme-linked immunosorbent assay (elisa) was used to determine the concentration of interleukin 17 (il-17) in gingival crevicular fluid (gcf).

Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis had at least 20 natural teeth, with probing pocket depth (ppd) ≥ 5 mm and attachment loss ≥ 4 mm exclusion criteria: * exclusion criteria were pregnancy, lactation, smoking, and any systemic disease that might affect periodontal disease progression or require antibiotic usage. likewise, patients who had received anti-inflammatory medications or antibiotics in the preceding three months were excluded.
study of hand therapy 3 to 24 months after stroke

Conditions: Cerebrovascular Accident

Summary: the primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. we hypothesize that the therapy group will improve hand function more than a customary and usual care group.

many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. the control group will receive device treatment for 3 months following their final evaluation. the results will provide valuable data on the ability of monitored home therapy to provide effective treatment. this project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Eligibility criteria:
inclusion criteria: * 3 to 24 months post stroke * able to extend wrist and fingers at least 10 degrees * functional hearing and vision * able to follow instructions * lives at home, not institution * stable medications for 3 months exclusion criteria: * excessive cognitive impairments * taking/receiving medicines/shots to make arm/hand less stiff * severe pain in the impaired arm * stroke was more than 24 months ago

Keywords: stroke rehabilitation stroke therapy hand therapy stroke cerebrovascular stroke cerebral stroke
nonmyeloablative allogeneic transplant

Conditions: Aplastic Anemia; Paroxysmal Nocturnal Hemoglobinuria; Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma; Multiple Myeloma; Waldenstrom Macroglobulinemia; Breast Cancer; Renal Cell Carcinoma; Melanoma; Sarcoma; Ovarian Cancer; Thymoma

Summary: allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

same

Eligibility criteria:
inclusion criteria: 1. age \> 55 years or 2. age \< 55 and lvef \< 45% or creatinine clearance \< 60 ml/min 3. ability to cover the cost of the transplant, necessary medications, and transportation/housing. 4. caregiver must be available while outpatient guidelines for cladribine-melphalan-based conditioning: * bone marrow failure states severe aplastic anemia (relapsed following immunosuppressive therapy) paroxysmal nocturnal hemoglobinuria (poor prognostic features or hemosiderosis) * aml (first cr except for t(15;17), inv16, t(8,21); second cr; relapse failing second induction attempt) * all (first cr with at least one poor prognostic feature; second or greater cr; relapse failing reinduction attempt) * mds (raeb, raebit, cmmol) * cml (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy * hodgkin's lymphoma (first or greater relapse) * non-hodgkin's lymphoma * aggressive histology (includes t cell nhl) incomplete response to induction second cr sensitive or refractory relapse * indolent histology second or greater relapse * mantle cell lymphoma (any stage - must have received induction chemotherapy) * multiple myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant) * waldenstrom macroglobulinemia (must have failed either purine analogue-based chemotherapy (fludara or 2cda) or standard cvp therapy; hyperviscosity or cytopenias) guidelines for total lymphoid irradiation-based conditioning * mds (ra, rars) * cll (rai stage iii or iv - must have received at least two different treatment regimens in the past) * breast cancer (symptomatic metastatic disease, who have failed standard chemotherapy) * renal cell cancer (metastatic disease at multiple sites) * malignant melanoma (metastatic disease at multiple sites) * sarcoma (all subtypes presently, unresectable metastatic disease) * ovarian cancer (stage iii or iv, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy) * thymoma (unresectable disease) exclusion criteria: 1. prior allogeneic stem cell or bone marrow transplant 2. current or past history of invasive mycotic infection 3. breast feeding

Keywords: nonmyeloablative transplant allogeneic transplant transplant
mobile health intervention

Conditions: Obesity

Summary: the purpose of this study is to evaluate the efficacy of a distance follow-up on body mass index decrease at 15 months compared to traditional management in obese adolescents.

childhood obesity continues to be a key challenge in france. the unit is facing a high demand with limited resources, moreover despite an intensive program of care with a multidisciplinary dedicated team, the impact on weight loss is moderate. the hypothesis is to ameliorate results by using distance monitoring in maintenance phase. after a traditional intensive period consisting in a weekly family-based multidisciplinary intervention, patients are randomized in two arms, traditional or distance follow-up. traditional follow-up is based on face-to-face multidisciplinary consultations every three months. the distance monitoring is based on a mobile application dedicated to food behavior change and physical activity, with weekly self-monitoring, goal setting, physical activity and healthy eating support, monthly weight assessment. pre-programmed feedbacks "motivational strategies" are included. after one year of follow-up, adolescents are evaluated for weight loss, compliance and quality of life. the two groups will be compared. the question is can mobile apps help to monitor and promote healthy lifestyle in obese adolescents.

Eligibility criteria:
inclusion criteria: * 11-17 years old * body mass index \> 97th percentile using french reference * non syndromic obesity * appropriate understanding of the study * appropriate understanding of french language, and ability in writing and reading exclusion criteria: * mental disability, severe and uncontrolled psychiatric disorders. * syndromic obesity, endocrine disorders or drug-induced obesity * other therapeutic: bariatric surgery, medications for weight loss * enrolment in an other therapeutic study

Keywords: obesity children adolescents new technology mobile health chronic disease
heat loss prevention in delivery room using a polyethylene cap

Conditions: Hypothermia, Preterm Infants

Summary: it is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss. we conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. furthermore, we assessed body temperature 1 hour after admission to neonatal intensive care unit (nicu) to evaluate whether the polyethylene cap prevents postnatal heat loss.

the primary outcome measure was axillary temperature taken on admission to the nicu (immediately after cap and wrap removal) and again 1 hour later. axillary temperature was measured using a digital thermometer (terumo digital clinical thermometer c202, terumo corporation, tokio, japan). the occurrence of hypothermia, defined as axillary temperature less then 36.4°c, on nicu admission was also evaluated. secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on nicu admission.

Eligibility criteria:
inclusion criteria: * infants \<29 weeks' gestation born in the study center. exclusion criteria: * congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.

Keywords: delivery room, polyethylene cap, preterm infant, temperature
impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis

Conditions: Periodontitis; Bruxism

Summary: this study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .

patients with chronic periodontitis usually describe itching and persistent pain of moderate intensity. applying masticatory pressure provides relief in these symptoms. however, this practice may lead to the development of bruxism habits in patients over time. a deeper comprehension of the dynamic interplay between periodontal health and bruxism is crucial for crafting holistic treatment approaches aimed at addressing both symptoms and root causes effectively. till now, there has been no report examining the effect of subgingival instrumentation on probable bruxers in periodontitis patients. . this study aims to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers in patients with periodontitis

Eligibility criteria:
inclusion criteria: * 1. systemically healthy patients 2. patient having habit of bruxism diagnosed with periodontitis 3. age between 30-40 years 4. minimum 20 teeth present in oral cavity exclusion criteria: 1. history of systemic disease such as diabetes or autoimmune disease 2. history of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs. 3. pregnant or lactating females. 4. post-menopausal women. 5. patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles 6. patients receiving interventions for bruxism. 7. history of psychological disorders

Keywords: inflammation